Liquid sample collection and transport system

ABSTRACT

A lid for a liquid sample container is provided which includes an opening for transferring the sample into a further container for conducting the necessary tests and a flexible portion, which allows the sample to be expelled through the opening. The opening is normally closed by a detachable closure which can also be used to re-seal the opening after the desired quantity of the sample has been withdrawn. An apparatus is also provided for obtaining dual liquid samples, which comprises two sample containers, wherein one container is retained within a recess in the other to result in a unitary structure. Further a method of obtaining liquid samples is provided which utilizes containers of the present invention.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to devices for collecting andtransporting liquid samples. More particularly, the subject devices areused for collecting and transporting samples of liquids for analyticaltesting.

2. Description of the Prior Art

The sampling of fluids for diagnostic or evidentiary purposes is verycommon. Such fluids, which include urine, blood, water, milk etc., arecollected in a specimen container and transported to a laboratory wherethey are analyzed to determine the presence of infections orcontaminants such as drugs, alcohol etc. Under such circumstances, thecollected sample must be maintained uncontaminated until the varioustesting procedures have been concluded. Containers for this purpose arecommon and usually comprise a plastic container having a secure lid.

The first step in analyzing the sample is normally the extraction of analiquot of the collected fluid. Since the collected samples may pose abiohazard risk, great care must be taken to ensure that the liquidsample is not spilled during the handling of the container or theextraction of the desired aliquot. Further, in order to protect theaccuracy of the analytical results, it must be ensured that nocontaminants mix with the sample.

It is now preferred for the analytical process to be automated whichinvolves the use of robotics to handle the specimen container and toconduct the various chemical and biochemical tests on the liquid sample.To conduct the desired tests, an aliquot of the sample is extracted fromthe vial and passed into a testing chamber (a test tube for example). Asmentioned above, it must be ensured that the fluid sample is not spilledonto any part of the apparatus and that, during the extraction of suchaliquot, another sample or other material does not contaminate thesample. Thus, specimen containers must be designed to be suitable foruse in both manual and automated analytical processes.

Another issue arises in cases where biological samples are collected forevidentiary purposes. In such situations, the established protocols callfor two samples of fluid to be collected and maintained in separatecontainers. One of such samples proceeds through the analytical processwhile the second is maintained uncontaminated for later reference ifneeded. In these cases it is important to maintain a proper chain ofcustody of the two samples so as to prevent tampering. Normally, thesample is collected in a collection cup and separated into transportcontainers, which are attached together, usually by rubber bands, untilthey reach the laboratory. Although the containers are labeled, they caneasily be misplaced rendering further verification of the testsimpossible and corrupting the chain of custody.

To address the safe transfer of the desired aliquot of the sample,various modifications to the container lid have been proposed. Anexample of such modification is described in U.S. Pat. No. 5,395,590wherein Swaniger et al. teach a valved plastic lid for a specimencontainer. The '590 lid includes a valved opening in the center whichcomprises a number of slits, which, due to the elasticity of the plasticmaterial, are normally closed. However, upon applying an inward force tothe lid, the slits open and allow the contained fluid to pass through.In extracting fluid from a container having such lid, the opening of asecond container, such as a test tube, is placed over the opening in thelid and the two containers are inverted. The first container is thenforced downward thereby causing the slits in the lid to open andallowing fluid to enter the second container. However, the lid taught inthe '590 patent has certain disadvantages. For example, the slits in thelid can be forced open prior to the testing process by applying pressurethereto and thereby allowing contaminants to enter the container.Similarly, the collected sample may also be inadvertently spilledthereby requiring a separate closure until the sample is extracted.Further, the manufacture of such a complicated structure adds to thecost of such a lid.

In U.S. Pat. No. 4,917,867, Jensen et al. teach an apparatus for thecollection of dual biological samples. This reference describes a kitcomprising a container containing two sample vials and other items toobtain the desired samples. After collecting the samples, the vials areplaced back into the main container. Although accounting for the chainof custody during transfer, the apparatus of this reference requires theseparation of the sample vials prior to the analysis process therebyresulting in the possibility of one of them being misplaced.

Thus a need exists for a specimen container which overcomes theabove-identified deficiencies in the known devices.

SUMMARY OF THE INVENTION

Therefore the present invention provides, in one aspect, a flexible lidfor a container containing a liquid, the lid comprising:

a means for securing the lid to the container to form a sealtherebetween;

a spout having an opening for transferring the liquid to a secondcontainer;

a removable closure for the opening, the closure maintaining the openingin a normally closed state; and,

a flexible portion surrounding the spout which permits the spout to moveinwardly into the container whereby the liquid is expelled through theopening after

removal of the closure.

In another aspect, the invention provides an apparatus containing liquidsamples comprising:

a first container having a receptacle and a lid;

the first container receptacle having an internal cavity opening to thebottom of the first container;

a second container having a receptacle and a lid;

the second container being received within the cavity in the firstcontainer receptacle and being releasably secured within the cavity.

In yet another aspect, the invention provides a method of collecting andtesting liquid samples using a collection container including a flexiblelid, the lid comprising:

a means for securing the lid to the collection container to form a sealtherebetween;

a spout having an opening for transferring the liquid to a testingcontainer;

a removable closure for the opening, the closure maintaining the openingin a normally closed state; and,

a flexible portion surrounding the spout which permits the spout to moveinwardly into the collection container whereby the liquid is expelledthrough the opening after removal of the closure

the method comprising:

a) removing the lid, transferring the sample into the collectioncontainer and securing the lid on the collection container;

b) transporting the collection container to a testing area;

c) removing the closure on the lid thereby exposing the opening;

d) locating a testing container above the opening and bringing thetesting container into contact with the lid whereby the opening opensinto the testing container;

e) inverting the testing and collection containers;

f) moving the testing and collection containers towards each otherwhereby the lid is flexed inwardly towards the interior of thecollection container thereby expelling a controlled portion of thesample into the testing container;

g) separating the collection container from the testing container; and,

h) proceeding with the required tests on the portion of the sample inthe testing container.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features of the preferred embodiments of the inventionwill become more apparent in the following detailed description in whichreference is made to the appended drawings wherein:

FIG. 1 is a cross sectional view through the central longitudinal axisof a specimen container in accordance with one embodiment of the presentinvention.

FIG. 2 is a cross sectional view of a specimen container in accordancewith another embodiment of the present invention.

FIG. 3 is a side view of the container of FIG. 2 with the lid removed.

FIG. 4 is a bottom view of the container of FIG. 3.

FIG. 5 is a cross sectional view of a sample container lid in accordancewith another embodiment.

FIG. 6 is a top view of the lid for the container of FIGS. 1 or 2.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, a specimen container in accordance with a firstembodiment is shown generally at 10. The container includes a lid 12,according to an embodiment of the invention, and a receptacle 14 forcontaining the liquid sample. The receptacle 14 is of a standard designand includes a threaded upper portion 16 which engages a correspondingthreaded portion 18 of the lid 12, thereby allowing the lid to besecured to the receptacle. In the preferred situation, the lid is formedof a flexible thermoplastic material and the receptacle is of agenerally cylindrical structure also formed of a thermoplastic material.Preferably, both the lid and receptacle are formed of polypropylene toallow for recycling of the materials.

In the embodiment shown in FIG. 1, the lid 12 includes a well 20 and aspout portion 22 located in the center of the lid. The well 20 of thelid 12 is bounded by a bottom surface 24 and a sidewall 25. Bottomsurface 24 generally slopes upward from its junction with the sidewall25, at the outer circumference, to the center spout portion 22. Thespout portion 22 comprises a funnel 28 having an opening 26. The spoutportion further comprises an uneven bearing surface 30 the purpose ofwhich is described below. Bearing surface 30, in a preferred embodiment,has a plurality of ribs 31 that radiate in a direction towards the outercircumference of the lid. In an alternative embodiment, the ribs may bereplaced by grooves.

The opening 26 is dimensioned so that, when the container 10 is invertedwith the closure 32 removed, air cannot enter the container due to thesurface tension of the liquid contained within. Accordingly, the liquidis prevented from exiting the container. For example, for samplescomprising water or aqueous solutions, the opening 26 has a diameter of≦0.04 in. For other liquids, the diameter of the opening 26 will dependupon its surface tension.

The opening 26 is sealed by a closure 32, which is integrally formedwith the lid 12 and is connected to the funnel 28 by means of ajunction34. The junction 34 is made of the same thermoplastic material as thefunnel 28 and the closure 32 but is of a thinner construction. Theweakness of the junction 34 allows the closure 32 to be separated fromthe funnel 28 upon application of sufficient force. The closure 32includes a pin 36 and a plurality of projections 38, which facilitatethe manual, or automated gripping of the closure 32. In a preferredembodiment, the projections 38 comprise a plurality of arms that extendupwardly and radially thereby forming a concave region 40 around the pin36. Alternatively, the projections 38 can consist of ribs.

The outer surface 42 of the side wall 25 includes a rim 43 which extendsradially outward of the lid 12 and which bears against the inner surface44 of the receptacle 14 to form, preferably, an air tight seal therewithwhen the lid is engaged on the receptacle. The bottom surface 24 of thewell 20 includes a weakened portion 46 between the sidewall 25 and thespout portion 22. The weakened portion is formed by reducing thethickness of the thermoplastic material in the desired region. Thus, thebottom surface of the lid is made flexible in the region of the weakenedportion 46 for the purpose described below.

Preferably, the outer surface 19 of the lid 12 includes conventionalvertical ribs to aid in detaching the lid from the receptacle 14.

Further, in the preferred embodiment, the closure 32 does not extendabove the rim 27 of the lid 12 so as to permit stacking of thecontainers 10 and the application of a security sealing tape, whennecessary.

In operation, the lid 12 is removed from the receptacle 14, a fluidsample is introduced and the lid is secured to the receptacle. Forwithdrawing the desired aliquot of the sample, the closure 32 is twistedcausing the junction 34 to break and thereby exposing the opening 26.The projections 38 assist in removal of the closure 32 by providingleverage for such twisting motion. A test tube (not shown) or othersimilar container for receiving the aliquot is inverted and placed overthe spout portion 22 so that the rim of the opening of such test tuberests on the uneven bearing surface 30. Both the specimen container 10and the test tube are then inverted thereby causing the fluid sample tofill the spout portion 22 and particularly the funnel 28. Since air isprevented from entering the container 10, the fluid sample does not leakfrom the opening 26. To extract the aliquot, the specimen container 10and/or the test tube are moved towards each other causing the weakenedportion 46 to flex inwardly and, in turn, forcing the spout portion 22towards the interior of the receptacle 14. The inward movement of thespout portion 22 leads to an increase in pressure within the receptaclewhich, in turn, forces a portion of the fluid in the container to exitthe opening and to collect in the test tube. The weakened portion 46 canbe designed to deliver a specific, or controlled, volume of liquid. Thisis achieved by designing the weakened portion to flex by a specifiedamount.

The ribs 31, on the uneven bearing surface 30 of the lid, providechannels for the air in the test tube to escape when displaced by theentering fluid.

The specimen container is then separated from the test tube and turnedupright. This removes the inward force on weakened portion 46 causing itto resume its normal raised position thereby reducing the internalpressure of specimen container 10. The vacuum created within thecontainer due to such pressure drop causes any liquid remaining in theopening 26 and any drop clinging to the opening to be sucked back intothe receptacle and prevents any further fluid from dripping out of theopening 26.

In order to prevent spillage of the sample fluid after the aboveprocess, the opening 26 is closed by heat sealing. In the preferredmethod, the heat sealing step involves the application of a foil overthe opening and the application of heat onto the foil. In such manner,the heating source does not come into contact with the opening andprevents such source from being contaminated by the sample. In thealternative, the closure 32 may be inverted and the pin 36 inserted intothe opening 26. To accommodate the latter closing method, the region 40is designed to cover the funnel 28.

As mentioned previously, these testing steps can be carried out in anautomated process wherein robotics are used to manipulate thecontainers, test tubes and other components.

In another embodiment, the test tube need not be in contact with the lid12. In this embodiment, the contained fluid can be expelled in the samemanner as above but by using a retaining device to support the container10 above the test tube.

FIG. 2 illustrates a further embodiment of the present invention forhandling a fluid sample, which has been transferred into two separatecontainers. In this embodiment, like elements are indicated with likereference numerals and the letter "a" is added for clarity. The specimencontainer according to this embodiment is indicated generally at 10a.The complete specimen container includes a first fluid sample container49 having a lid 12 such as described above. Alternatively, the lid forthe first container 49 can be any conventional lid known in the priorart. In the embodiment shown, the generally cylindrical first container49 also includes a fluid sample receptacle 14a comprising a fluidcontaining chamber 50 and legs 52 and 54 which define a generallycylindrical recess 56. A second fluid sample container 58 is disposedwithin the recess 56. The second container 58 comprises a receptacle 60and a lid 62. As above, the lid 62 is screwed onto the receptacle 60. Toensure that separation of the two containers does not occur, theexterior surface 64 of the second container 58 and the surface of therecess 56 are ribbed so as to provide a friction fit there between.

The lid 62 of the second container 58 includes an annular recess 66around its outer edge and directed towards the interior of thereceptacle 60. A lid of this structure is described in U.S. Pat. No.5,460,283. The recess 66 is positioned so that, when the lid 62 isengaged on the receptacle 60, the outer wall 68 of the annular recess 66is pressed against the inner wall 70 thereby forming a seal between thelid 62 and the receptacle 60 to prevent leakage of the contained liquid.In an alternative embodiment, a conventional lid may be used for thesecond container 58. In another embodiment, a rim 72 may be provided onthe inner wall 70 of the receptacle 60. The rim 72 is then biasedagainst the outer wall 68 of the recess 66 when the lid is secured.

In the preferred embodiment, the second container 58 does not extendbeyond the legs 52 and 54 of the first container so as to enable thecomplete specimen container 10a to stand on legs 52 and 54.

FIGS. 3 and 4 illustrate different views of the receptacle 14a. As shownthe legs 52 and 54, when viewed on end, are generally crescent shapedand follow the outer generally cylindrical surface of the receptacle14a. The receptacle 14a includes two slots 74 and 76 located betweenlegs 52 and 54. Slots 74 and 76 allow the lid 62 of the second container58 to be grasped so as to permit extraction of the second fluidcontainer 58 from the recess 56 of the first fluid container 49.

In a further embodiment, the second fluid container 58 may be screwedinto the recess 56 instead of using the friction fit as mentioned above.

In using the dual container 10a as described above, the second container58 is first separated from the first container 49 and both lids 12 and62 are removed. The liquid sample is transferred into receptacles 50 and60. Both lids 12 and 62 are replaced onto to the respective receptacles50 and 60 and the second container 58 is inserted into the recess 56 asshown in FIG. 2. The first container 49 contains the sample to be testedwhile the second container 58 contains a duplicate sample for futurereference. During the testing process, the steps discussed above arefollowed.

A further, preferred embodiment of the lid is shown in FIG. 5 whereinlike elements are identified by like reference numerals and wherein theletter "b" is used for clarity. The lid of this embodiment is shown at12b. The lid 12b has most of the same components as the previousembodiment of the lid 12 described above. However, the bearing surface30b of this embodiment generally follows the slope of the funnel 28. Thebearing surface 30b includes ribs 31b to provide an uneven surface asdescribed above.

FIG. 6 is a top view of the lid 12 and illustrates the ribs 31 of thebearing surface 30. As shown, four ribs are provided which radiateoutwardly from the center of the lid.

In another embodiment, the lids 12 and 12a can also be secured to thereceptacle 14 by a snap fit.

Although the invention has been described with reference to certainspecific embodiments, various modifications thereof will be apparent tothose skilled in the art without departing from the spirit and scope ofthe invention as outlined in the claims appended hereto.

The embodiment of the invention in which an exclusive property Orprivilege is claimed are defined as follows:
 1. A flexible lid for acontainer containing a liquid, said lid comprising:a means for securingsaid lid to said container to form a seal therebetween; a spout havingan opening for transferring said liquid to a second container; aremovable closure for maintaining said opening in a normally closedstate, wherein said closure is integrally formed with said lid and isseparable therefrom, a flexible portion surrounding said spout whichpermits said spout to move inwardly into said container whereby saidliquid is expelled through said opening after removal of said closure;wherein said flexible portion includes a bearing surface surroundingsaid spout for bearing against an opening in said second containerduring the liquid transfer process.
 2. A lid as claimed in claim 1wherein a weakened portion joins said closure to said lid, said weakenedportion being breakable thereby permitting separation of said closurefrom said lid.
 3. A lid as claimed in claim 2 wherein said closure,after being removed, can be replaced on said opening for sealing saidopening.
 4. A lid as claimed in claim 3 wherein said closure includesprojections for providing leverage when separating said closure fromsaid lid.
 5. A lid as claimed in claim 1 wherein a top portion of saidlid is recessed into the interior of said container.
 6. A lid as claimedin claim 1 wherein said bearing surface includes a means for allowingpassage of air from said second container.